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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSYNCHROMED II INFUSION SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS138
Date Received08/10/2010
Decision Date03/03/2011
Product Code LKK 
Advisory Committee General Hospital
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL OF THE FOLLOWING MANUFACTURING PROCESS CHANGES RELATED TO THE BASELINE TEST OF THE IMPLANTABLE SYNCHROMED II INFUSION PUMP, MODEL 8637: 1) AUTOMATION OF THE TRANSFER OF BASELINE TEST DATA; 2) CHANGE THE DUTY CYCLE AND LOWER THE SPECIFICATION LIMIT OF THE DYNAMIC CURRENT TEST; AND 3) AN INCREASE TO THE TIME TO MEASURE THE MICRO AWAKE CURRENT.
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